Anne Arundel Medical Center Informed Consent Version 2: December 1, 2008
Identification of Genomic Biomarkers in Lichen Sclerosus
Research Consent Form
Identification of Genomic Biomarkers in Lichen Sclerosus
GW IRB Reference number: 070721
IRBNET Reference number: 96296-1
Principal Investigator or Study Doctor: Andrew Goldstein, MD
Telephone number: 202-887-0568
Sub Investigator: Sidney Fu, MD, Ph.D. Telephone number: 202-994-4767
Sponsor: The Catherine Birch McCormick Genomics Center, George Washington University
1) INTRODUCTION
You are being invited to take part in a research study. Before you decide if you want to participate in this research study, it is important for you to understand why the research is being done and what it will involve. This consent form describes the purpose, procedures, benefits, risks, discomforts, and precautions of the study.
Please take time to read the following information carefully and discuss it with friends, relatives, or your family doctor if you wish. Please ask if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. You will be given a signed copy of this consent to take home with you.
Your participation in this study is entirely voluntary. You may choose not to take part, or you may withdraw from the study at any time. In either case, you will not lose any benefits to which you are otherwise entitled. You do not have to take part in this study to receive care at The Center for Vulvovaginal Disorders or George Washington University. You may not receive any benefit from taking part in this study, however, the research may give us knowledge that may help people in the future.
This study is being conducted by Dr. Andrew Goldstein (Department of Obstetrics and Gynecology of the George Washington University Medical Center and Director, the Centers for Vulvovaginal Disorders) and Dr. Sidney Fu (Department of Biochemistry and Molecular Biology of the George Washington University Medical Center.
2) WHY IS THIS STUDY BEING DONE?
You are being asked to take part in this study because you have the skin condition called lichen sclerosus (LS). LS is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction and/or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.
By engaging in the study, we hope to learn which genes are turned on and which genes are turned off in skin affected by LS as compared to normal skin in order to understand LS, and further to develop effective drugs to treat the condition.
The research will be conducted at the following locations: The Centers for Vulvovaginal Disorders (2002 Medical Parkway, Suite 215, Annapolis Maryland 21401 or 3 Washington Circle NW, suite 205, Washington DC 20037) and the Department of Biochemistry and Molecular Biology of the George Washington University Medical Center.
3) HOW MANY PEOPLE WILL TAKE PART IN THE STUDY
Six participants will be asked to take part in this study. All participants will be recruited from the Centers for Vulvovaginal Disorders ((2002 Medical Parkway, Suite 215, Annapolis Maryland 21401 or 3 Washington Circle NW, suite 205, Washington DC 20037) Participants must have a biopsy proven diagnosis of lichen sclerosus and have the signs and symptoms of active lichen sclerosus
4) WHAT IS INVOLVED IN THIS STUDY?
If you decide to take part in this research study, you will undergo the following procedures that are not part of your standard medical care: Two additional skin biopsies and about a teaspoon of blood will be drawn from your arm.
If you choose to take part in this study, this is what will happen: You will be asked details of your medical history as well as the medical history of your family members. Dr. Andrew Goldstein will then perform a thorough examination of your vulva. Dr. Goldstein will then take three 5mm (¼ inch) skin biopsies, two of skin affected by LS and one of normal skin. Prior to the biopsies, a numbing medication (lidocaine) will be injected in the biopsy sites. After the biopsies, you will get one or two stitches at each biopsy site. These stitches dissolve and do not have to be removed. The biopsy specimens will be placed in liquid nitrogen and transported to the George Washington University Medical Center. In addition, two tubes of blood (about a teaspoon) will be drawn from a vein in your arm.
Your biopsies and blood samples will not be stored with your name but will instead be given a study number.
5) HOW LONG WILL I BE IN THIS STUDY?
The total amount of time you will spend in connection with this study is approximately 60 minutes.
All samples obtained in this study will be processed for RNA and DNA extraction, which will be used for gene expression analysis. Remaining RNA and DNA will be stored at the George Washington University School of Medicine for a period of 5 years for further verification studies if needed, and then they will be destroyed. Your name will not be on these specimens.
6) WHAT ARE THE RISKS OF PARTICIPATING IN THIS STUDY?
Possible risks, discomforts and inconveniences that you could experience during this study from the vulvar biopsies and blood draw include pain, bleeding, scarring, infection, and bruising. You will not be able to engage in sexual activity until the biopsies heal in approximately 10-14 days.
Disease Specific or Genetic Testing
Disease testing and genetic research raises certain questions about informing you of any results. Possible risks of knowing results include: anxiety; other psychological distress; and the possibility of insurance and job discrimination. A possible risk of not knowing includes being unaware of the need for treatment. These risks can change depending on the nature and results of the research and whether there is a treatment or cure for a particular disease. Sometimes patients have been required to furnish information from genetic testing for health insurance, life insurance, and/or a job.
Even with special precautions, there is no absolute protection against discrimination on the basis of disease or genetic information. For this reason, the study Doctors will use the results of this study as research only and not include them in your medical record.
7) ARE THERE POTENTIAL BENEFITS TO TAKING PART IN THIS STUDY?
If you agree to take part in this study, there will not be direct medical benefit to you. We hope the information learned from this study will benefit individuals with lichen sclerosus in the future or aid in our understanding of lichen sclerosus.
8) WHAT ARE MY OPTIONS?
You do not have to take part in this study if you do not want to participate.
9) WILL I RECEIVE PAYMENT FOR BEING IN THIS STUDY?
No payment will be provided for participating in this study.
10 WHAT WILL IT COST ME IF I DECIDE TO PARTICIPATE IN THIS STUDY?
There will be no additional costs to you as a result of taking part in this study. However, you are responsible for all routine medical care for your condition (the care you would receive whether or not you were in this study).
11) ARE THE RESEARCHERS BEING PAID FOR THE STUDY?
The sponsor of the study is not paying George Washington University or the Study Doctors for their work in this study.
12) WHO PAYS FOR MY MEDICAL CARE IF I BECOME ILL OR INJURED BECAUSE OF THE STUDY?
The researchers have taken steps to minimize the known or expected risks. In spite of all precautions, you still may experience medical complications or side effects from participating in this study. If you believe that you have been injured from taking part in this study, you should seek medical treatment from Dr. Andrew Goldstein at The Centers for Vulvovaginal Disorders. You will not be billed for any care for such injuries from Dr. Goldstein. However, if you seek care from another physician or require hospitalization for the care of such injuries you will be billed in the ordinary manner to you or your insurance company. You also should promptly notify Dr. Andrew Goldstein (202) 887-0568 in the event of any illness or injury.
You will not receive any financial payments from Dr. Andrew Goldstein, The Centers for Vulvovaginal Disorders, Dr. Sidney Fu, or George Washington University for any injuries or illnesses. You do not waive any liability rights for personal injury by signing this form.
13) WHAT ABOUT CONFIDENTIALITY?
Your information will be kept as confidential as possible. Access to study records will be limited to those who need the information for purposes of this study, as well as your health care providers should they need access to the information. All records are kept in a secure location at The Centers for Vulvovaginal Disorders and the George Washington University Department of biochemistry in a password protected database, and access is limited to research study personnel.
Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed, unless you give the appropriate authorization.
14) HOW WILL MY PRIVACY BE PROTECTED?
Federal law requires that hospitals, researchers and other healthcare providers (like physicians and labs) protect the privacy of health information that identifies you. This kind of information is known as “protected health information” or “PHI.” This section tells you your rights about your protected health information in the study. This section also lists who you let use, release, and get your protected health information. You are free to not allow these uses and releases by not signing this form. If you do that though, you cannot participate in the study.
Protected health information that may be used and released (disclosed) in this study includes information such as:
· This consent form;
· Demographic information (like your name, address, date of birth, social security number, etc.);
· Information about your medical history from your medical records and your doctor’s office;
· Information obtained from you to be used in the Study as a result of tests or procedures;
· Results of physical examinations
· Laboratory results obtained on specimens collected from you (blood, tissue);
· Interviews with you conducted by members of the Research Team;
· Other data created or collected during this study.
By signing this form, you allow the use, sharing, copying, and release of your protected health information to carry out the study by:
· your healthcare providers (like doctors and hospitals) which are not part of the study,
· the Study Doctor and his or her research team, and
· other healthcare providers such as labs which are part of the study.
You also allow the Study Doctor and his or her research team, and other healthcare providers which are part of the study to release your health information to:
· Anne Arundel Medical Center Institutional Review Board (“IRB” “A group of people who review the research study to help guarantee that the rights, safety, and welfare of participants are protected and that the study is carried out in an ethical manner.”) or its authorized representatives, as well as representatives of the Office of Human Research Protections (OHRP) who may review your records to ensure that your rights as a research subject are protected;
· the sponsor of the study and any contractors or partners it may have. (research monitors and auditors)
· Accrediting agencies and legal counsel
· clinical staff who are not involved in the study who may become involved in your care, if it might be relevant to your care.
You may request to review or have a copy of your personal health information collected during this study and placed in your medical record. This right to review and copy your personal health information only extends to information that is placed in your medical record; it does not extend to information that is placed in your research record.
This permission does not end unless you cancel it, even if you leave the study. You can cancel this permission any time except where a healthcare provider has already used or released your health information, or relied on your permission to do something. Even if you cancel this authorization, the researchers may still use and disclose protected health information they already have obtained about you as necessary to maintain the integrity or reliability of the research. However, no PHI information or new biological specimens will be collected from you after you revoke your authorization.
To cancel your authorization, you will need to send a letter to Dr. Andrew Goldstein of The Centers for Vulvovaginal Disorders stating that you are canceling your authorization. This letter must be signed and dated and sent to this address: The Centers for Vulvovaginal Disorders 3 Washington Circle NW, Suite 205 Washington, DC 20037. A copy of this revocation will be provided to the Study Doctor and his or her research team. Not signing this form or later canceling your permission will not affect your health care treatment outside the study, payment for health care from a health plan, or ability to get health plan benefits.